N/A
N=127
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Stoma Ileostomy
Bottom Line
View on ClinicalTrials.gov: NCT01994902 ↗Enrolled (actual)
127
Serious AEs
3.7%
Results posted
Jan 2016
Primary outcome: Primary: Degree of Leakage — 5.1; 5.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coloplast test product (Device); SenSura Convex Light (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Coloplast A/S
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Leakage |
5.1; 5.8 | — |
Summary
The aim of the investigation was to investigate the performance and safety of a new ostomy product.
Eligibility Criteria
Inclusion Criteria
- Are at least 18 years of age and have full legal capacity.
- Has had an ileostomy for at least 3 months.
- Has used a convex ostomy product for the last month.
- Has given signed informed consent.
- Has experienced seeping under the baseplate at least three times during the last two weeks.
- Currently using a SenSura Convex product with midi, maxi or magnum bags.
- Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").
- Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.
Exclusion Criteria
- Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).
- Are pregnant or breastfeeding.
- Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.
- Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.
- Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.
- Are currently participating in another clinical intervention study or have previously participated in this one.
- Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.
- Has known hypersensitivity toward the test product.
Data sourced from ClinicalTrials.gov (NCT01994902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.